BIOBALL® End User Agreement
Application to Import BIOBALL®
1.Company Information
1.Company Information
State/Province
Intended use of BIOBALL®
2.What is the intended use of BIOBALL®? (Please review the definitions for clarification of each intended use)
2.What is the intended use of BIOBALL®? (Please review the definitions for clarification of each intended use)
 
3.Provide a description of the work to be accomplished with the BIOBALL® product(s)(Describe your work clearly and simply. Include background, purpose, objective, methods, etc.)
4. Will the agent(s) be propagated or cultured?
4. Will the agent(s) be propagated or cultured?
5. Will the agent(s) be used to inoculate animals or arthropods?
5. Will the agent(s) be used to inoculate animals or arthropods?
Biosafety Measures
6.What is the Biosafety Level (BSL) of you location?
6.What is the Biosafety Level (BSL) of you location?
7.What is the primary containment that will be used?
7.What is the primary containment that will be used?
 
8.What personal protective measures will be used?
8.What personal protective measures will be used?
 
9.What personnel training has been provided?
9.What personnel training has been provided?
 
10.Do you have biosafety measures implemented appropriate for any hazard that may by posed by BIOBALL® and its intended uses?
10.Do you have biosafety measures implemented appropriate for any hazard that may by posed by BIOBALL® and its intended uses?
In accordance with bioMérieux’s USDA PPQ 526 permit (# P526P-19-03245) all end-users using BIOBALL® must be informed of the conditions of this permit and anyone working with these microorganisms must agree to adhere to and sign/initial these conditions prior to beginning work.  The conditions of this permit apply to the following microorganisms:Achromobacter xylosoxidansAcidovorax spp.Acinetobacter baumanniiAcinetobacter johnsoniiAcinetobacter lwoffiiAgrobacterium spp.Aspergillus aculeatusAspergillus brasiliensisAspergillus creberAspergillus fumigatusAspergillus japonicasAspergillus sydowiiAspergillus tamariiAspergillus versicolorBacillus spp.Burkholderia cenocepaciaBurkholderia cepaciaBurkholderia multivoransCandida spp.Citrobacter freundiiCladosporium spp.Clavibacter michiganensisDelftia acidovoransEnterobacter spp.Fusarium spp.Gluconacetobacter liquefaciensKocuria palustrisKocuria rhizophilaLactobacillus plantarumLasiodiplodia pseudotheobromaeMethylobacterium extorquensMethylobacterium fujisawaenseMethylobacterium organophilumMicrobacterium arborescensMicrobacterium paraoxydansMicrococcus spp.Penicillium spp.Pichia guilliermondiiPseudomonas aeruginosaPseudomonas alcaligenesPseudomonas fluorescensPseudomonas putidaPseudomonas stutzeriSphingomonas spp.Stenotrophomonas maltophilia End-User AgreementAs an end-user of the listed BIOBALL® strains, I agree to the following:Without prior notice and during reasonable hours, authorized Federal and/or State Regulators shall be permitted to inspect the conditions associated with the regulated materials/organisms authorized under this permit.This location must have facilities that are adequate to prevent the unauthorized dissemination of the regulated live organisms received under this permit.  Access to this facility must be restricted from the general public.All regulated materials/organisms must be stored or maintained in an area that is not accessible to the general public.All regulated materials/organisms and all items coming into contact or exposed to the regulated materials/organisms must be sterilized/sanitized/decontaminated (see below) prior to removal from the authorized containment facility. Prior to disposal or reuse, all contaminated and all potentially contaminated materials must be treated by one of the following methods:Autoclaved at 121°C for a minimum of 30 minutes at 15 psi (see USDA  Autoclave protocol LINK)Disposed of off-site by a facility holding a valid PPQ compliance agreement (organisms and/or contaminated waste must be stored in sealed containers prior to pick-up by this company)IncineratedImmersed in 5,250-6,000 PPM sodium hypochloride solution (1 part fresh household bleach to 9 parts water) for at least 20 minutesImmersed in 70% alcohol for at least 30 minutes.Treated waste will be double bagged prior to disposal.Other sterilization methods are only allowed with prior written agreement from USDA/APHIS PPQ Pest Permit Staff. By signing this document the person(s) working with the listed organisms regulated under this permit acknowledges that she /he has read them and agrees to comply with all permit requirements and permit conditions.For more information:  http://www.aphis.usda.gov/plant_health/index.shtml.
In accordance with bioMérieux’s USDA PPQ 526 permit (# P526P-19-03245) all end-users using BIOBALL® must be informed of the conditions of this permit and anyone working with these microorganisms must agree to adhere to and sign/initial these conditions prior to beginning work. 

The conditions of this permit apply to the following microorganisms:

Achromobacter xylosoxidans

Acidovorax spp.

Acinetobacter baumannii

Acinetobacter johnsonii

Acinetobacter lwoffii

Agrobacterium spp.

Aspergillus aculeatus

Aspergillus brasiliensis

Aspergillus creber

Aspergillus fumigatus

Aspergillus japonicas

Aspergillus sydowii

Aspergillus tamarii

Aspergillus versicolor

Bacillus spp.

Burkholderia cenocepacia

Burkholderia cepacia

Burkholderia multivorans

Candida spp.

Citrobacter freundii

Cladosporium spp.

Clavibacter michiganensis

Delftia acidovorans

Enterobacter spp.

Fusarium spp.

Gluconacetobacter liquefaciens

Kocuria palustris

Kocuria rhizophila

Lactobacillus plantarum

Lasiodiplodia pseudotheobromae

Methylobacterium extorquens

Methylobacterium fujisawaense

Methylobacterium organophilum

Microbacterium arborescens

Microbacterium paraoxydans

Micrococcus spp.

Penicillium spp.

Pichia guilliermondii

Pseudomonas aeruginosa

Pseudomonas alcaligenes

Pseudomonas fluorescens

Pseudomonas putida

Pseudomonas stutzeri

Sphingomonas spp.

Stenotrophomonas maltophilia

 

End-User Agreement

As an end-user of the listed BIOBALL® strains, I agree to the following:

  • Without prior notice and during reasonable hours, authorized Federal and/or State Regulators shall be permitted to inspect the conditions associated with the regulated materials/organisms authorized under this permit.
  • This location must have facilities that are adequate to prevent the unauthorized dissemination of the regulated live organisms received under this permit.  Access to this facility must be restricted from the general public.
  • All regulated materials/organisms must be stored or maintained in an area that is not accessible to the general public.
  • All regulated materials/organisms and all items coming into contact or exposed to the regulated materials/organisms must be sterilized/sanitized/decontaminated (see below) prior to removal from the authorized containment facility. 
    • Prior to disposal or reuse, all contaminated and all potentially contaminated materials must be treated by one of the following methods:
      • Autoclaved at 121°C for a minimum of 30 minutes at 15 psi (see USDA  Autoclave protocol LINK)
      • Disposed of off-site by a facility holding a valid PPQ compliance agreement (organisms and/or contaminated waste must be stored in sealed containers prior to pick-up by this company)
      • Incinerated
      • Immersed in 5,250-6,000 PPM sodium hypochloride solution (1 part fresh household bleach to 9 parts water) for at least 20 minutes
      • Immersed in 70% alcohol for at least 30 minutes.
      • Treated waste will be double bagged prior to disposal.
      • Other sterilization methods are only allowed with prior written agreement from USDA/APHIS PPQ Pest Permit Staff. 

By signing this document the person(s) working with the listed organisms regulated under this permit acknowledges that she /he has read them and agrees to comply with all permit requirements and permit conditions.

For more information:  http://www.aphis.usda.gov/plant_health/index.shtml.